Drugs.com - New Drug Approvals

1. FDA Approves Jideytro (zidesamtinib) for Previously Treated ROS1-Positive Non-Small Cell Lung Cancer

   London, UK July 22, 2026 -- GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) has approved Jideytro (zidesamtinib), a ROS1 selective inhibitor, for the treatment of adult patients with locally advanced or metastatic...

2. Glenmark Receives U.S. FDA Approval to Expand the Use of Ryaltris Nasal Spray for Children Aged 6 to Less Than 12 Years

   Elmwood Park, New Jersey, July 21, 2026: Glenmark Specialty S.A. (Glenmark) today announced that U.S. FDA has approved the expanded use of Ryaltris (olopatadine hydrochloride and mometasone furoate) Nasal Spray, 665 mcg/25 mcg per spray, for the...

3. Novartis Fabhalta (iptacopan) Receives FDA Traditional Approval as First and Only Complement Inhibitor to Significantly Slow Kidney Function Decline in Primary IgAN

   Basel, July 17, 2026 – Novartis today announced that the US Food and Drug Administration (FDA) has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN)...

4. FDA Approves Lipfendra (enlicitide) Oral PCSK9 Inhibitor to Reduce LDL-C in Adults with Hypercholesterolemia

   RAHWAY, N.J.--(BUSINESS WIRE) July 16, 2026 -- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) has approved Lipfendra (enlicitide) tablets 20 mg as an adjunct to...

5. FDA Grants Traditional Approval to Retevmo (selpercatinib) for Locally Advanced or Metastatic RET Fusion-Positive Solid Tumors

   On July 14, 2026, the Food and Drug Administration granted traditional approval to selpercatinib (Retevmo, Eli Lilly and Company) for adult and pediatric patients two years of age and older with locally advanced or metastatic solid tumors with a RET...

6. FDA Approves Revtorpyk (gedatolisib) for the Treatment of HR+/HER2-, PIK3CA Wild-Type Locally Advanced or Metastatic Breast Cancer

   MINNEAPOLIS, July 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced that the U.S. Food and Drug...

7. FDA Approves Leqembi Iqlik (lecanemab-irmb) Subcutaneous Injection as an Initiation Dose for Early Alzheimer’s Disease

   TOKYO and CAMBRIDGE, Mass., July 13, 2026 (GLOBE NEWSWIRE) -- Eisai Co., Ltd. and Biogen Inc. (Nasdaq: BIIB), announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a...

8. FDA Approves Sarclisa Escena (isatuximab-irfc) Subcutaneous Injection for the Treatment of Multiple Myeloma

   Paris, July 10, 2026. The US Food and Drug Administration (FDA) has approved subcutaneous (SC) Sarclisa (isatuximab-irfc) Escena in combination with standard-of-care regimens for the treatment of patients with multiple myeloma (MM) across all...